An agency of the European Union
Referentials Management Services (RMS)
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
Presented by: Jaume Gonzalez Nogueras
Business Lead for RMS
An agency of the European Union
Status Update
What has been done since last TF
• RMS SG TCs:
• 22 March 2016: management of
standard terms requests
• 20 April 2016: RMS implementation +
CVs for OMS + CVs from the 80
elements for PMS iteration 1 (Material)
+ management of standard terms
requests
• 31 May 2016: ATC-like codes/national
classification systems
• 15 June 2016: ATC-like codes/national
classification systems
• Ad hoc Webinars:
• 30 November & 16 December 2015:
Translations
• 13 January 2016: Change requests
• 10 February 2016: Subscriptions, User
preferences, Tags, Search and Saved
queries
• 09 March 2016: RMS API - intro
• 15 March 2016: OID
• 17 March 2016: UAT
• 06 April 2016: RMS API – details
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
RMS subgroup work
2
Ad hoc Webinars
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• API specification, messaging format and schema
Introduction to the API specification document (06 April 2016)
Review of specification document complete (comments by 20 May)
• RMS web portal screen mock-up sessions
Sessions since 2015 and into early 2016.
Functionality: Browse, Search, downloads, change request, translations, subscriptions, tags,
user preferences
Based on system use cases already signed off
User registration part not covered
3
Joint RMS & OMS subgroup work
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• CVs for OMS
5 new lists requested to be created in RMS (Party Category, Party Category Type, Title, OMS
Request Reason and OMS Request Rejection Reason)
3 existing EUTCT lists (Country, Language and Source of Information) – already migrated to
RMS
Definition of each list to be provided in the future (documentation to be generated)
• Preparation work for the UAT
Over 100 testers nominated for each of RMS and OMS UATs
All stakeholder groups are represented
UAT delayed to Q4 2016 due to RMS/OMS project replanning
On-boarding of UAT Testers webinar booked for 19 July
UAT plan and test cases already drafted pending their review after 19 July webinar
4
Joint RMS & S/PMS subgroup work
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Review of CV Q&A
Review of the Q&A for the CVs in the 80 elements required for PMS iteration 1
Identified need for 3 new lists: materials, individual roles, organisation roles.
Individual roles & Organisation roles: to be defined by regulatory context with
PMS implementation
• Material
simple materials only; no combinations
hierarchy of materials catering for both specific and non-specific terms
no description needed
short names/acronyms needed for searching but will not be preferred name
amendments to the list proposed by R Subgroup
on hold, P to clarify the need for materials
5
Joint RMS & S/PMS subgroup work
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• ATC like terms
RMS Project is consolidating xEVMPD ATC list with EUTCT WHO ATC Human list
xEVMPD codes with status “development” & ”proposed” => provisional in RMS (public!)
xEVMPD codes “Not assigned” & “Not applicable” => no CV, will become null flavour
WHO ATC Herbal codes => very few may be needed (doubtful business case): option to include required ATC herbal codes in national classification list to be explored.
ATC-like codes => 2 options:
1. separate flat list containing everything ≠ WHO ATC Human codes (if business case justified)
2. No list maintained (i.e. applicants to choose null flavour “not applicable” or similar)
6
RMS and EDQM
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Policy discussion
EDQM and RMS lists serve similar but nonetheless different use cases. Although the lists will
be vastly overlapping some differences are accepted:
EDQM EMA
• Purpose: supports regulatory use cases (mostly Marketing application process but possibly also CT and PhVig)
• Pending: normally only publishes terms if/once approved
• Rejected: does not publish all rejected terms only relevant examples
• Deprecated: only deprecates terms which were ST, does not consider legacy terms which may have been used in approved products if they were never ST
• Purpose: support all use cases, regulatory or other (prescription, data management/application integration)
• Provisional: publishes all terms while they are still being accessed
• Nullified: publishes all terms regardless of outcome which includes rejected/nullified terms
• Non-Current: considers any term that may have ever been used in approved products regardless of being ST (contains EDQM term ID and source of information) or not (does not refer to EDQM term ID)
• “Clean” list of recommended terms • Comprehensive collection of terms used/required
7
RMS and EDQM
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Use case discussion
The differences across the lists will be dealt as follows:
EMA EDQM EMA
Invalidate change request (CR) (no terms created) e.g. incomplete details; synonyms
NA NA
Validate CR & Create Provisional term
Approve CR & Publish ST
Approve CR Update term status to Current Update term details with EDQM file
Reject CR & Publish rejected ST
Reject CR Update terms status to Nullified Update term details with EDQM file
Reject CR & Not Publish rejected ST
Reject CR Update term status to Nullified (irrelevant example) OR Update term status to Non-current (legacy term)
8
RMS and EDQM
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Use case discussion
EMA and EDQM have agreed on:
the process to guarantee matching of terms/requests: EDQM will include the RMS term ID in
their API
dealing with multiple requests for the same/similar term: one change request which is
updated to reference subsequent requests and only one outcome
how specific EUTCT/EV terms will be included in ST i.e. how to cope with multiple requests at
one time and limited product details: working through excel
how to process requests when the term is created in one list (e.g. dosage forms) but
approved in another (e.g. combined terms): nullify initial term and create a new one in the
final list
9
RMS and Bfarm
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Interim maintenance by EMA
In July 2015 EUNDB decided that Bfarm is the EU maintenance organisation for the Units of
Measurement (UoM)
By April 2016 RMS design stage should have been complete and Bfarm was not yet ready to
become the list owner
EMA will go live with our data model and we will be “interim” maintenance organisation for UoM
We don’t replace the decision of July 2015 and BfArM will be the “maintenance organisation” in
future.
BfArM will take the time and necessary actions to “align” with our requirements
Once they are ready, we need to start a new project to implement the TOM with BfArM in
accordance with our requirements.
10
RMS & WHO
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Common understanding – ATC H & V
Users of RMS can:
browse the ATC list in a flat structure but not more than 100 terms are available per page so
that the full list is never displayed in its entirety;
browse the ATC list in a hierarchical structure. They may be able to expand several nodes of the
hierarchy but only one active path at a time i.e. for ATC list maximum of 5 nodes are expanded.
perform searches using the ATC hierarchy or using one or more individual ATC terms. ATC terms
(the text and code) can be provided as a result of a query and can be viewed on screen, printed,
or exported in electronic form.
NCA users may be able to export the ATC list from RMS in CSV and XML format (RMS format,
common format across all lists) or access it via the API. All of ATC data will be made available.
Industry and public users will not be able to export/download the ATC list from RMS
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RMS & WHO
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Common understanding
Managing Change requests: Industry needs to request new/updated terms to WHO and to EMA
EMA will receive yearly updates but WHO also publishes temporary codes on their website
WHO have no automated mechanism to inform users/EMA of changes apart from yearly update
so EMA needs to be prompted upon request
WHO EMA
Term is NOT in “New ATC codes and alterations”
& the company has only has a proof of submission => Invalidate change request (CR) (no terms created)
& the company has confirmation in writing from WHO with an ATC code proposal => Validate CR & Create Provisional term
Term is in “New ATC codes and alterations” as temporary
Validate CR & Create Provisional term
Term is in “New ATC codes and alterations” as final
Validate CR & Create Provisional term Then Approve CR & Update term status to Current
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RMS & WHO
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Common understanding
Maintenance process:
The term remains as provisional until such point in time where EMA receives the annual WHO
ATC excel update. If term is provisional in RMS and
is published as final on WHO file => EMA updates it to Current
WHO assigns a different term as final=> EMA updates the provisional term to Nullified (and creates
the final ATC code as Current if new)
Translations:
EMA will purchase the ATC Index in English, Spanish (and Norwegian?) from WHO.
EMA may collect other translations as provided by the NCAS/Other government bodies and
include them in the same list.
13
RMS Operating Model particularities RMS
All these lists will be held in RMS
RMS/EUTCT EDQM Bfarm/ UCUM*
WHO MSSO
- Country/Language - Target species, Vet lists - EudraCT lists, TIGes
lists, etc - VedDRA
- Dosage Forms - Routes of
Administration - Containers/packaging - Units of Presentation
- Units of measurement
* Done by EMA in the first phase
- ATC Human - ATC Vet - INN
- MedDRA
Lists in RMS to which stakeholders have access
Download/access lists via RMS Yes Yes Yes Yes Yes
Requests changes to lists/terms via RMS
Yes Mostly for legacy Unlikely in other cases, Industry should have done it in advance
Yes Mostly for legacy Unlikely in other cases, Industry should have done it in advance
Yes Mostly for legacy Unlikely in other cases, Industry should have done it in advance
Request to WHO first and then to EMA
No, request to MSSO Only available in EMA via updates from MSO
Add/amend translations via RMS
Yes No, through EDQM only Yes Yes No
Download/access lists via RMS Yes Yes Yes No Browse only Access through WHO
No Browse only Access through MSSO
Requests changes to lists/terms via RMS
Yes Yes Yes Request to WHO first and then to EMA
No, request to MSSO Only available in EMA via updates from MSO
Add/amend translations via RMS
No No No No No
RMS business process
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Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016) 14
RMS project work
• Design work complete: Logical data model, detailed requirements, business process and all
system use cases (release 1 and 2)
• Release 1 go live 15 June!
• foundation infrastructure for the delivery of SPOR services: master data, data quality, workflow, services
and webportal
• Data: migrated some of the data from EUTCT; changed some key EUTCT lists significantly to make their
structure ISO compliant as per ISO 11239 (Dosage forms, Routes of administration, packaging) and ISO
11240 (units of measurement)
• Functionality: list publication (& internal data management) - We will start managing future OMS lists in
production shortly
• Web portal (UI) & corresponding API: limited functionality; mostly restricted to browsing lists/terms.
• Release 2 underway
• MDM tools configuration and system testing under way
• RMS solution training material drafting in progress
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016) 15
RMS network engagement activities
• NCAS
NCAs have been requested to start mapping of Dosage Forms, Routes of
Administration and Packaging
EMA has hosted dedicated mapping webinar to support them
• Industry
No mapping required at the moment
The focus is on establishing Change Liaison network
• Vets
Engagement recently started and activity plan still to be agreed
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016) 16
An agency of the European Union
Next steps
Presented by: Kepa Amutxastegi/Ana Cochino
RMS subgroup work
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• API specification, messaging format and schema
Approved API specifications expected by June
• RMS web portal screen mock-up session
Demo of release 1 and run through of system mock-ups for release 2 functionality planned for
July
•Discussions/further analysis:
Creating the user population for go-live
UAT planning and execution
User guides & training material
etc
18
Joint RMS & S/PMS subgroup work
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Material
P to clarify the need for materials vs substance list
• ATC like terms
ATC-like codes => 2 options:
1.separate flat list containing everything ≠ WHO ATC Human codes (if business case justified)
2.No list maintained (i.e. applicants to choose null flavour “not applicable” or similar).
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RMS & Maintenance Organisations
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• EDQM
Non-EU terms available in EDQM mappings and whether they are needed in RMS
How RMS will deal with EDQM mappings
When a term is validly constructed but not applicable to the product in question
• Bfarm
Whether Bfarm can support EMA with change requests in the interim
• WHO
WHO will discuss and decide if they want to receive/adopt translations provided by NCAs
• MSSO
Review how MedDRA can be used in the context of RMS
• Kew Gardens
Initiate possible engagement to support SMS
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RMS project
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016)
• Preparation for the UAT
Set up of the SPOR Web portal UAT environment
Set up of MDM tools UAT environment (change request management)
Preparation of test data for the UAT
• Provide required support for UAT execution
Ensure testers can perform all test cases
Collect all the test results
Fix all the blocking, critical or major defects
• Prepare for go-live release - TBD
21
Thank you
Status update – EU Network Data Board / SPOR Task Force (29, 30 June – 1 July 2016) 22
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